The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for D-10 Hemoglobin A1c.
| Device ID | K031043 |
| 510k Number | K031043 |
| Device Name: | D-10 HEMOGLOBIN A1C |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | BIO-RAD LABORATORIES, INC. 4000 ALFRED NOBEL DR. Hercules, CA 94547 |
| Contact | Jackie Buckley |
| Correspondent | Jackie Buckley BIO-RAD LABORATORIES, INC. 4000 ALFRED NOBEL DR. Hercules, CA 94547 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-01 |
| Decision Date | 2003-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847817003417 | K031043 | 000 |
| 00847817003400 | K031043 | 000 |
| 00847817003356 | K031043 | 000 |
| 00847817003318 | K031043 | 000 |
| 00847817003301 | K031043 | 000 |
| 00847817003295 | K031043 | 000 |
| 00847817003288 | K031043 | 000 |
| 00847817003271 | K031043 | 000 |
| 00847817000089 | K031043 | 000 |